(84 days)
Intended to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
The Alcohawk Precision™ is designed to measure deep lung air to test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1 The Alcohawk Precision™ is a D.O.T. approved alcohol screening device and uses a blow time of 5 seconds to capture an accurate deep lung sample. The Alcohawk Precision™ contains a semiconductor oxide sensor designed to test for the presence of alcohol. Gas sensitive semiconductor material is formed on an alumina substrate on which the gold electrodes are printed. A thick film heater of ruthenium oxide is printed on the reverse of the substrate and placed in the plastic housing. The tin dioxide (SnO2) metal oxide semiconductor material is heated to a specific temperature. The resistance of sensing material changes rapidly according to gas concentration changes, thereby enabling the reading of alcohol concentration by resistance measurement.
Here's a breakdown of the Alcohawk Precision™ device's acceptance criteria and the study information based on the provided text:
Acceptance Criteria and Device Performance
| Feature | Acceptance Criteria (Predicate Device: AlcoMate CA2000 K041334) | Reported Device Performance (Alcohawk Precision™) | Meets Criteria? |
|---|---|---|---|
| INDICATION For USE | Intended to measure alcohol in human breath; measurements used in diagnosis of alcohol intoxication. | SAME | Yes |
| MODE | Breath Alcohol Concentration | SAME | Yes |
| PRACTITIONER USE | Over the Counter | SAME | Yes |
| DISPLAY | 3 Digit LED | 4 Digit LED | N/A (Improvement) |
| POWER SOURCE | 9 Volt Alkaline Battery | SAME | Yes |
| BATTERY LIFE | 300 Tests | 100-300 tests | Yes (within range) |
| Measurement Range | .00-.40% | SAME | Yes |
| Accuracy | +/-0.01% | SAME (+/- .009%) | Yes (meets or exceeds) |
| TYPE OF SENSOR | Semiconductor-Oxide Sensor | SAME | Yes |
| ANATOMICAL SITE | Mouth | SAME | Yes |
| Mouthpiece | Replaceable | SAME | Yes |
| Warm Up Time | 20 Seconds | 15-60 Seconds | Yes (within range) |
| Blowing Time | 5 Seconds | SAME | Yes |
| DOT Approval | YES | YES | Yes |
| Construction | Plastic case with internal circuit board | SAME | Yes |
| SIZE | 5" x 3 ½" | 4.25" x 2.75" | N/A (Difference in physical attributes) |
| WEIGHT | 200 grams | 130 grams | N/A (Difference in physical attributes) |
Note: The 'N/A' for some features indicates that while there are differences, they are either improvements (e.g., 4-digit LED display) or physical attributes that do not directly relate to the device's functional performance or safety compared to the predicate, and thus do not constitute a failure to meet acceptance criteria in the context of substantial equivalence. The key functional criteria like indication for use, accuracy, measurement range, and sensor type are either identical or meet/exceed the predicate.
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "user testing data" and "bench tests", "DOT testing", but the specific number of participants or tests for the "clinical trial" is not provided.
- Data Provenance: The document does not specify the country of origin for the data. The "user testing data" combined with a "clinical trial" suggests prospective data collection.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: The document mentions that the clinical trial results were "comparable to those provided by a professional unit administered by a trained observer." This implies the ground truth was established by "trained observers" using "professional units," but their specific qualifications (e.g., medical professionals, certified breath alcohol technicians) are not detailed.
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Adjudication method for the test set:
- The document does not describe a formal adjudication method (e.g., 2+1, 3+1). It states that the device could "obtain results that were comparable to those provided by a professional unit administered by a trained observer," suggesting a comparison against a reference standard.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a standalone breath alcohol detector, not an AI-assisted diagnostic tool that involves human readers or interpretation of complex data by radiologists/experts. Therefore, an MRMC study is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the device is inherently a standalone device. The "clinical trial" was performed to establish that users could properly use the device and the device would obtain "comparable results" to a professional unit. This implies evaluating the device's performance directly, independent of human interpretive assistance (beyond basic user operation). The accuracy specified (+/- 0.009%) is for the device itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by measurements from "a professional unit administered by a trained observer." This suggests a reference measurement from a validated, higher-standard breath alcohol testing system. It is a form of reference standard comparison rather than expert consensus on images or pathology.
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The sample size for the training set:
- Not applicable. This device is a hardware-based sensor system with a semiconductor oxide sensor, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The device's operation is based on established physical and chemical principles, not learned patterns from data.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.
§ 862.3050 Breath-alcohol test system.
(a)
Identification. A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.